Home / 510(k) Clearances / K854944

510(k) K854944

TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT by Abbott Laboratories — Product Code DAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gamma Globulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Abbott Laboratories

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K232669 — TBI (September 29, 2023)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K220031 — Alinity h-series System (August 4, 2023)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)

Other clearances for product code DAH

  • K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (April 27, 1993)
  • K905149 — TITAN GEL (January 3, 1991)
  • K901805 — REP(R) IMMUNOFIX (June 6, 1990)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN G (September 7, 1988)
  • K862184 — DAKO ITA, IMMUNOGLOBULIN M (IGM) (August 19, 1986)